November 17, 2009 - This FOA has been updated to reflect the new requirements from NIH’s Enhancing Peer Review Initiative. The new requirements are effective for submissions intended for due dates January 25, 2010 and beyond. If submitting an application intended for a due date of January 25, 2010 and beyond, follow the guidance below and be sure to use the 06/2009 version of the PHS 398 application forms and instructions. If applying for a due date before January 25, 2010, follow the guidance in the archived version of this FOA and be sure to use the 11/2007 version of the PHS 398 application forms and instructions.

Key Dates
Release/Posted Date: June 11, 2009Letters of
Intent Receipt Date(s): March 19, 2010; March 19, 2011; March 19,
2012Application Due Date(s): April
19, 2010; April 19, 2011; April 19, 2012Peer Review Date(s): July 2010; July 2011; July 2012Council Review Date(s): October
2010; October 2011; October 2012 Earliest Anticipated
Start Date(s): December 2010; December 2011; December 2012Additional
Information To Be Available Date (Activation Date):Not
ApplicableExpiration Date:
April 20, 2012

Due Dates for
E.O. 12372

Not
Applicable.

Additional Overview
Content

Executive Summary

Purpose. With this Funding
Opportunity Announcement (FOA), the National Cancer Institute (NCI) invites applications for linked awards using the NIH P20 funding mechanism and intended for
feasibility studies to assist researchers and faculty at Minority-Serving
Institutions (MSIs) establish collaborative partnerships with the researchers
and faculty of NCI-designated Cancer Centers (or other institutions with
highly-organized, integrated research efforts focused on cancer). This FOA is
designed to facilitate planning and implementation of focused collaborations in
cancer-related research, training, career development, education, and/or
outreach. The sole intent of the P20 partnership awards is to provide support
for cancer projects and programs for limited durations of time to perform
feasibility studies and obtain preliminary data that will lead to the
submission of specific competitive grant applications for support by the NCI
and/or other sources of peer-reviewed funding.

Funds Available and Anticipated Number
of Awards. The combined direct cost budgeted in the two linked
applications from the MSI and the Cancer Center together cannot exceed
$275,000. Awards issued under this FOA are contingent upon the
availability of funds and the submission of a sufficient number of meritorious
applications.

Budget
and Project Period. Applicants may request support for up to
4 years. Because the nature and scope of the proposed research will vary from
application to application, it is anticipated that the size and duration of
each award will also vary.

Research Strategy Page Limitations. For
specific limits, see Section IV. 2. Content and Form of Application Submission.

Eligible Project
Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources
necessary to carry out the proposed research are invited to work with their
institution/organization to develop an application for support. Individuals
from underrepresented
racial and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Number of PDs/PIs. More than one PD/PI,
or multiple PDs/PIs, may be designated on the application.

Number
of Applications. Applicants may submit more than one application, provided that each
application is scientifically distinct.

Resubmissions. Applicants may submit a resubmission application, but
such application must include an Introduction addressing the previous peer
review critique (Summary Statement). See new NIH policy on resubmission
(amended) applications (NOT-OD-09-003, NOT-OD-09-016).

Renewals.Renewal applications will not be accepted.

See Section IV.1 for
application materials. All applications, including resubmission, revision and renewal, submitted for due dates January 25, 2010 and beyond, must utilize the current forms and instructions.

Hearing Impaired. Telecommunications for the
hearing impaired are available at: TTY 301-451-5936.

The
National Cancer Institute (NCI) invites linked award applications for
feasibility studies to help researchers and faculty at Minority-Serving
Institutions (MSIs) establish collaborative partnerships with the
researchers and faculty of NCI-designated Cancer Centers (or other
institutions with highly organized, integrated research efforts focused on
cancer). The awards (using the NIH P20 mechanisms) are designed to
facilitate planning and implementation of focused collaborations in
cancer-related research, training, career development, education, and/or
outreach. The sole intent of these P20 partnership awards is to provide support
for cancer projects and programs for a limited time to perform feasibility
studies and obtain preliminary data that will lead to the submission of
specific competitive grant applications for support by the NCI and/or other
sources of peer-reviewed funding.

MSIs are defined as institutions
at which students of minority groups that are underrepresented in the
biomedical sciences (e.g., African Americans, Hispanics, Native Americans,
Alaskan Natives, Native Hawaiians, Pacific Islanders), comprise a significant
proportion of the enrollments and at which there have been documented records
of commitment to the special encouragement of minority faculty, students, and
investigators.

Feasibility
Studies for Collaborative Interactions must be focused on promoting and
conducting collaborative activities between the MSI and the Cancer Center in one or more of the targeted areas:

1)Collaborative
cancer research project(s);

2)Collaborative
training and career development programs designed to train students and scientists;

3)Collaborative
cancer education programs designed to create new curriculum to apprise and
culturally sensitize high school, undergraduate, and/or graduate students in
cancer health disparities and motivate them to pursue cancer research careers; and

4)Collaborative
cancer outreach research programs designed as proactive efforts to help
minority communities develop and manage their own culturally sensitive programs
for educating their populations about cancer risk, early detection, screening,
prevention, and treatment.

The
ultimate objective of the programs proposed for the P20 linked awards must be
the submission of competitive applications to the NIH/NCI for funding by
mechanisms such as:

Comparable funding mechanisms at other research
funding organizations (e.g., American Cancer Society).

Background

Cancer Disparities. The disparities in cancer incidence, morbidity, and
mortality in racial and ethnic minority populations and among the
socio-economically disadvantaged have continued to rise over several decades,
despite the progress in other aspects of the War on Cancer that began in
1971. For example, the incidences of colon and lung cancers in Alaska Native
and African-American men and women are higher than that of other ethnic groups.
The 5-year survival rates in the Native American, African American, Hawaiian,
and Hispanic American populations are lower than in the Japanese and White Americans
populations; and patterns of prostate cancer among African American males
compared with White males, seen in the Southeastern United States (U.S.),
particularly in rural areas, remain higher (http://www.nci.nih.gov/atlasplus/ ). Clearly, more research is needed that specifically
addresses these and other disparities if they are to be eliminated by 2010 (http://www.healthypeople.gov/default.htm). This initiative is also in line with the priority
recommendations for U.S. Department of Health and Human Services (DHHS) to lead
the Nation in eliminating cancer health disparities (Making Cancer Health
Disparities History, http://www.hhs.gov/chdprg) and The NCI Strategic Plan (http://strategicplan.nci.nih.gov).

Cancer
Disparity Research in Minority-Serving Institutions (MSIs). MSIs conduct high quality programs for educating
minorities and they represent a rich source of talent with appropriate cultural
sensitivity and perspectives needed in cancer research. However, they have had
difficulties developing and sustaining independent programs in biomedical
research, and there is a paucity of minority scientists pursuing successful
biomedical research careers. Despite various initiatives, progress in realizing
a significant increase in the number of underrepresented minority scientists
who are competitive for National Institutes of Health (NIH) research grants has
been slow. More specifically, a serious shortage of well-trained
underrepresented minority scientists who can conduct independent cancer
research, and focus research efforts on the disproportionate burden of cancer
in racial and ethnic minority and socio-economically disadvantaged populations,
and whose cultural perspectives are essential to the successful conduct of
research involving these populations still exists.

Cancer
Disparity Research in Cancer Centers. The NCI-designated Cancer Centers are geographically dispersed,
research-intensive organizations with well-organized programs for training
cancer scientists. They are the major organized units supported by the NCI to
conduct cancer research; sponsor cancer-related research training in the basic,
clinical, and population sciences; provide information services; and develop
and sustain educational and outreach programs that benefit their communities.
Yet, Cancer Centers can (and should) play a greater role in facilitating the
following activities: (1) research pertinent to cancer in racial and ethnic
minorities and socio-economically disadvantaged groups; (2) training
underserved scientists; (3) reaching out to and partnering with different
racial, ethnic minority populations in their communities; and (4) bringing the
benefits of cancer research to these populations.

Specific Research Objectives

The Minority
Institution/Cancer Center Partnership (MICCP) program is aimed at building
excellence. It is strongly encouraged that the P20 application should
include some of the following components:

1. Career Developmental
Plan. Career and professional
development activities must be developed
for less experienced investigators from the MSI and Cancer Center, in particular junior investigators, and post-doctoral scientists involved in the
partnerships. For the purpose of this PA, a junior investigator is a scientist
and/or faculty member with no prior independent research funding from NIH or
equivalent agencies. Appropriate career development plans must be proposed for
individual researchers from the MSI and Cancer Center, for example for
scientists designated to serve as non-lead PIs or lead PIs. The objective of this endeavor is to increase the chances that junior
investigators develop the research skills and abilities needed to work in a
collaborative and competitive environment and will eventually become successful
independent cancer researchers.

2. Mentorship Plan. The career plan should identify mentor(s) who will be
responsible for career and professional development of these individuals.
Mentorship should involve senior faculty member(s) with research competence
and/or experience appropriate for the role. Mentors must be individuals from
the cancer center(s) with relevant research experience who have an appreciation
of the cultural, socioeconomic, and research backgrounds of the junior
investigators. When appropriate, experienced senior faculty within MSIs, but
outside the junior investigator's research area, may be chosen as consultants
or co-mentors. This approach is of particular significance when Cancer Center investigators with relevant research experience become mentors for less
experienced senior faculty from the MSIs. The mentor(s) and the junior
investigator are expected to closely interact during planning, developing, and
realizing of a tailored career development plan similar to the model used in
NIH career development awards. The mentoring process should include defining
the expected outcomes in a way clear to both mentor and mentee. The career
development plan should ensure that mentors are available to provide
appropriate guidance throughout the duration of the program. The Minority
Institution/Cancer Center Partnership (MI/CCP) application may provide compensation
for mentors, co-mentors, and/or consultants.

The feasibility studies
program sponsored by this FOA will stimulate and support (albeit not
indefinitely) the activities in the broad target areas listed below. All of
these activities are intended to eventually generate competitively funded
support through peer-reviewed funding mechanisms.

Target Areas

The P20 MI/CCP grant offers
four broad target areas for focused planning, development, and implementation,
which are described below. The application must propose at least one joint
project/program in any of these four targeted areas:

1) Cancer Research: A joint pilot research project may be in any area of
basic, clinical, prevention, control, behavioral, and/or population research. A
research project conducted primarily at the MSI may be in any area of cancer
research, but a research project conducted primarily at the Cancer Center must specifically address one or more areas of cancer disparity in minority and
underserved populations. Joint cancer research projects at MSIs might focus,
for example, on general areas of environmental carcinogenesis, molecular
epidemiology, and/or behavioral issues related to cancer prevention, treatment,
and/or control. Applicants are encouraged to consider joint research projects
that involve emerging technologies such as genomics, proteomics, and
nanotechnology. The expectation is that successful pilot research projects will
become competitively funded grants (e.g., R03, R01, project on a P01, project
on a P50).

2) Cancer Training: Joint training programs that link the faculty and
students of the MSI and the Cancer Center are the most productive ways to
sustain long-term effective partnerships. These programs must place an emphasis
on the training of minority scientists and on educating majority trainees to
appreciate the issues and problems associated with cancer disparities in
minority populations. The NCI particularly encourages training of
underrepresented minority scientists in clinical, behavioral, and population
research, and training that incorporates methods and tools of emerging
technologies such as genomics, proteomics, and nanotechnology; there is a huge
deficit of underrepresented minority scientists engaged in these research
areas, areas which are highly dependent for their success on the cultural
sensitivity of the researchers and in these leading edge technologies. These
training programs must represent true collaborations that function seamlessly
across the institutional boundaries of the MSI and the Cancer Center. For example, new training programs might provide graduate students at MSIs
opportunities to fulfill their research requirements in Cancer Center laboratories using state-of-the-art equipment and mentoring by Cancer Center investigators. On the other hand, Master degree programs at an MSI might be linked
formally to doctoral training programs at Cancer Centers. Clinical research
training programs at MSIs might also include rotations for medical students and
residents working in Cancer Center laboratories. Other training programs may
deal with minority cultural issues for majority trainees and clinical training
programs at the Cancer Center might offer the use of current methodologies for
national and international electronic communication on diagnosis and treatment
of cancer for minority trainees. Successful activities in this area may lead to
the submission of competitive training grant applications (e.g., T32, K12, R25)
as well as individual predoctoral fellowships (F31), individual postdoctoral
fellowships (F32 and F33), career development awards (K01, K08, K23, K22), and
research supplements for trainees. The cancer training
activities must include proper tracking of trainees and evaluation of the
program.

3) Cancer Education: Cancer education programs could focus on any effort to
augment existing or create new curricula in the MSI and/or the Cancer Center that would apprise and culturally sensitize high school, undergraduate,
graduate, and postdoctoral students in research, medicine, and public health of
the need to reduce the disproportionate cancer burden in minority populations.
Education programs that focus on teaching students about emerging technologies
such as genomics, proteomics, and nanotechnology that emphasize their use in
cancer research are encouraged. A successful effort may result in the
submission of a competitive NCI education grant application (R25) and that
later should yield to institutional commitments to make these curricula an
inherent component of their educational systems.

4) Collaborative Cancer Outreach: Cancer-related outreach programs in the context of this FOA are defined as proactive efforts to help minority
communities develop and manage their own culturally sensitive programs for
educating their populations about cancer risk, early detection, screening,
prevention, and treatment. MSIs and Cancer Centers would be expected to combine
their expertise in working with minority leaders and organizations in the
community to develop outreach programs that effectively reach individuals and
physicians and that increase the recruitment and retention of racial and ethnic
minorities into clinical trials and prevention protocols. The cancer outreach
activities must be hypothesis-driven and include proper research questions,
tracking, and evaluation.

Period
of Support

Applicants
may apply for up to 4 years of support under the P20 MI/CCP FOA. Applicants
requesting 4 years of support must clearly describe three stages of partnership
development: (i) a planning stage; (ii) a priority setting stage; and (iii) an
implementation stage. Applicants requesting shorter periods of support should
have already identified areas of potential collaboration through planning.
These applicants must document prior planning activities and clearly describe a
priority-setting stage and an implementation stage.

Because
the nature and scope of the proposed research will vary from application to
application, it is anticipated that the size and duration of each award will
also vary. Although the financial plans of the NCI provide support for this
program, awards pursuant to this funding opportunity are contingent upon the
availability of funds.

Note 1: Applicants may request a project period of up to four
years. The combined direct costs budgeted in the
two linked applications from the MSI and the Cancer Center together cannot exceed $275,000 per year. The amount requested should be appropriate to the stage of
partnership development, and take into account that the planning and
priority-setting stages are not as costly as the implementation stage. Budget
requests would be expected to escalate progressively from year 1 to year 4. Third party facilities and
administrative costs are excluded from direct cost caps and may be requested in
addition to the $275,000 direct cost limit (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html). Future years may include cost
of living adjustments of 3 percent over the maximum direct cost budget limit
for each institution in the partnership.

Note
2: The
P20 award will provide support for the following:

1)
Administrative costs (which may be higher in the early stage of
development and lower in the late stages) for managing the planning effort,
such as salaries for key personnel, travel for key personnel, equipment, and
supplies to support an administrative structure.

2)
Developmental costs for:

a) Initial Planning Stage, which should be focused on developing and organizing
workshops, seminars, retreats, and other forms of communication to explore
potential opportunities in cancer research, cancer training and career
development, or cancer education;

b) Priority-Setting Stage, which should be focused on selecting the areas
of greatest promise for implementation as specific types of pilot projects or
programs based on merit and potential to result in a successful grant
application. Pilot projects/programs cannot exceed $120,000 in direct costs per
year, and may not exceed 3 years; and

c) Implementation Stage, which should be focused on implementing pilot
research projects or pilot programs in training and career development,
education or outreach for the explicit purpose of obtaining preliminary data
for the submission of a specific grant application(s).

Facilities
and Administrative (F&A) costs requested by consortium participants are not
included in the direct cost limitation. See NOT-OD-05-004.

Number
of Applications. Applicants may submit more than one
application, provided each application is scientifically distinct, with
different PIs for each application.

Resubmissions. Applicants may submit a resubmission application, but such
application must include an Introduction addressing the previous peer review
critique (Summary Statement).Beginning with
applications intended for the January 25, 2009 official submission due date,
all original new applications (i.e., never submitted) and competing renewal
applications will be permitted only a single amendment (A1). See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016. Original new and
competing renewal applications that were submitted prior to January 25, 2009
will be permitted two amendments (A1 and A2). For these grandfathered
applications, NIH expects that any A2 will be submitted no later than January
7, 2011, and NIH will not accept A2 applications after that date.

Renewals. Renewal applications will not be
accepted.

In
addition, there are a number of Special Requirements and Provisions with which
each MI/CCP grant application must comply, such as the following:

1)
Number of concurrent applications/awards. In addition to this FOA using
the P20 mechanism, the MI/CCP programs use the U54 mechanism (see respective
links for the latest MI/CCP FOAs using these mechanisms:
http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-09-501.html). Each MSI and Cancer Center may not have more than one P20 award and one U54 award simultaneously
within the same partnering institutions. However, the institutions can
establish and apply for P20 partnerships with different partner institutions.

2)
Partnership Structure and Leadership. Each P20 MI/CCP application must be
submitted as a clearly documented partnership between the MSI and the Cancer Center. For each
partnership, two separate applications must be submitted: one from the MSI and
one from the Cancer Center. The overall objectives of the two applications must
be the same, but the actual activities and budgets of the two applications
should demonstrate how the MSI and the Cancer Center requests both differ and
complement each other in achieving their common objectives.

Contact PI: Each application
may have multiple PIs but one PI from each partnering institution is expected
to be designated contact PI. Even if there are no additional PIs from the
same institution, the contact PI on the application from the MSI should be
listed as PI on the linked application from the Cancer Center and the contact
PI on the application from the Cancer Center should be listed as PI on the
linked application from the MSI. When the PI from the MSI or Cancer Center is an individual with no prior experience as a PI on a peer reviewed grant, there
must be a written "Letter-of-Support" from a senior member (e.g.,
Department Chair, Dean, Cancer Center Director) of the MSI or Cancer Center. In the letter, the senior member is expected to indicate his/her qualifications and the willingness to
provide guidance to the inexperienced PI.

Turnover /Replacement of PI:
Any investigator turnover (replacement of a PI or a Co-Leader of
project/program) must be fully documented and approved by the NCI.
Documentation should include institutional commitment and support letters,
rationale for replacement in ensuring that they fall within the bounds of the
areas prioritized for development and stabilization and the goals and
objectives of the partnership, biographical sketches, and transition plans
(when appropriate).

3) Targeted Areas. The
Feasibility Studies for Collaborative Interaction must include any of the
following targeted areas:

cancer research;

cancer training and career development;

cancer education; and

cancer
outreach.

4)
Letters-of-Commitment. Each application must include written
"Letters-of-Commitment" from the MSI leadership and the Cancer Center leadership that are supportive of this activity and that commit the
additional resources necessary to ensure that these partnerships will have the
maximum chance of success. A complete and specific description of such
resources should include the following items:

A
specific statement detailing the percent effort of release/protected time (for MSI lead PI: a
minimum of 10 percent of effort and 25% of effort if there are no other PIs
from the MSI side of the partnership: lead PI from the Cancer Center: a minimum
of 10 percent of effort regardless of the number of PIs from the CC side of the
partnership) as well as the activities from which each faculty member involved is being
released (e.g., teaching, clinical, administrative duties); and

Provisions
for space and facilities availability for new projects/programs, capital
improvements, recruitment of new faculty, and other resources that may
contribute to the success of the partnership.

5)
Collaborative Planning Process. Depending upon prior experience, interactions, and
progress in planning, the two applications must clearly describe a
collaborative planning process that includes all of the following components:

Initial
Planning Stage, for which the participants must describe appropriate
means of communicating and identifying areas of potential collaborations and clearly
explain the participation and specific roles of the Internal Advisory Committee
(IAC, see below);

Priority-Setting
Stage,
for which the participants must select the areas of greatest promise for
implementation as specific types of pilot projects or programs based on merit
and potential to result in a successful grant application (the PIs from both
partnering components should describe the process used by the IAC to evaluate
new and ongoing pilot project/programs); and

Implementation
Stage, for which the participants acquire preliminary data from pilot project/programs
for submitting a specific competitive grant application (in any of the target
areas to the NCI or other funding agencies).

6)
Nature of Projects/Programs for Development. The applicants are required to propose at least one
joint project/program in any of the four targeted areas. To qualify, pilot projects and pilot programs must
represent totally new activities that do not overlap in purpose or intent with
existing funded grants (e.g., P30, P50,
P01, R01, National Center for Research Resources' Research Infrastructure
Grants, National Institute of General Medical Sciences' Minority Biomedical
Research Support Grants, EXPORT grants, Community Network Program grants, and
other peer-reviewed funded programs).

For
each proposed joint project/program, two project/program co-leaders must be
designated (one investigator from the MSI and one from Cancer Center).

7)
Internal Advisory Committee (IAC). The PIs from both partnering components will convene
a common Internal Advisory Committee (IAC) that will be made up of the PIs and
other key personnel, as appropriate, from both the MSI and the Cancer Center. The IAC must have equal numerical representation from the MSI and the Cancer Center. The expertise of the IAC members should be relevant to the objectives and
goals of the collaboration/partnership. If the committee lacks the scientific
expertise to evaluate applications for specific projects/programs, ad hoc
reviewers from either within or outside the partnering institutions may be
added to the IAC.

Evaluation
of Projects/Programs by IAC. Each new project/program should be evaluated for
scientific merit, relevance to the partnership objectives, potential to
generate publishable data for peer-reviewed journals, and potential to develop
into a competitive grant application to be submitted to NCI/NIH or other
equivalent funding agencies.

When
a project/program co-leader is a junior investigator, the application must be
evaluated for the appropriateness of the career development and mentorship
plan. In addition to reviewing and prioritizing new pilot projects/programs,
the IAC will also evaluate ongoing pilot projects/programs and advise the PIs
from both partnering components as to the general activities of the partnership
and how they may contribute effectively to achieving high priority goals and
objectives.

National Evaluation. The evaluation being
performed by the IAC is a local evaluation of their specific MI/CCP
partnership. All MI/CCP partnerships will be required to participate in a
national program evaluation. The national evaluation will be contracted out by
NCI to assess the effectiveness / success of the overall MI/CCP program in
achieving the goals and objectives enumerated in this FOA. For example, the
national evaluation will assess the extent to which the MI/CCP is fostering
better collaboration between MSI and Cancer Centers; the extent to which the
MI/CCP helps new investigators to become more competitive in securing NIH grant
awards; increase in access of underserved populations to beneficial cancer
diagnosis and treatment, etc.

Participation
in Program Evaluation. All PIs of the MI/CCP partnerships are expected to
participate and facilitate a national program evaluation that will be conducted
by an independent evaluation organization contracted by the NCI. Conducting the
national evaluation under contract ensures objectivity and credibility of the
evaluation findings and recommendations. The contractor shall seek the input
and cooperation of the PIs and NCI program officials in developing the program
logic models and in specifying the core data elements. However, the contractor
shall still conduct an objective / independent evaluation of the overall
program. Each MI/CCP partnership shall submit / transmit a set of core data
sets to the national program evaluator (at least semi-annually or periodically
as deemed feasible by the NCI and the PIs). The data sets will include both
quantitative and qualitative data necessary to adequately conduct a
comprehensive cross-site evaluation of the national multi-site MI/CCP program.
Data from local evaluations shall be provided to the national evaluation
contractor to supplement data submitted for the national evaluation.

8)
MI/CCP Workshop. All recipients of P20 MI/CCP awards will be expected
to participate in a biennial MI/CCP Workshop for sharing information and
strategies. Travel expenses for this purpose must be included in the grant
applications from the MSI and the Cancer Center.

9)
Studies Involving Native Americans (if applicable). If an application includes
participation of Native American (American Indian) or similar defined
populations, a formal letter-of-support from the Tribal Nation Leader or
equivalent must be included.

Applications must be
prepared using the current PHS 398 research grant application instructions and
forms (modified as defined in Section IV.6. Other Submission
requirements). Applications must have a D&B Data Universal Numbering System
(DUNS) number as the universal identifier when applying for Federal grants or
cooperative agreements. The D&B number can be obtained by calling (866)
705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should
be entered on line 11 of the face page of the PHS 398 form.

The title and
number of this funding opportunity must be typed in item (box) 2 of the face page of the application form and the YES box
must be checked.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs.

When multiple PD/PIs are
proposed, use the Face Page-Continued page to provide Items 3a 3h for all
PD/PIs. NIH requires one PD/PI be designated as the contact PD/PI for all
communications between the PD/PIs and the agency. The contact PD/PI must meet
all eligibility requirements for PD/PI status in the same way as other PD/PIs,
but has no special roles or responsibilities within the project team beyond
those mentioned above. The contact PD/PI may be changed during the project
period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face
Page), with all additional PD/PIs listed on Form Page 1-Continued. When
inserting the name of the PD/PI in the header of each application page, use the
name of the Contact PD/PI, et al. The contact PD/PI must be from the
applicant organization if the PDs/PIs are from more than one institution.

All individuals designated as
PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role
in that system (other roles will not give the PD/PI the appropriate access to
the application records). Each PD/PI must include their respective eRA Commons
ID in the eRA Commons User Name field.

All projects proposing
Multiple PDs/PIs will be required to include a new section describing the
leadership plan approach for the proposed project.

Multiple
PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new
section of the research plan, entitled Multiple PD/PI Leadership Plan must be
included. A rationale for choosing a multiple PD/PI approach should be
described. The governance and organizational structure of the leadership team
and the research project should be described, and should include communication
plans, process for making decisions on scientific direction, and procedures for
resolving conflicts.The roles and administrative, technical, and
scientific responsibilities for the project or program should be delineated for
the PDs/PIs and other collaborators.

If
budget allocation is planned, the distribution of resources to specific
components of the project or the individual PDs/PIs should be delineated in the
Leadership Plan. In the event of an award, the requested allocations may be
reflected in a footnote on the Notice of Award.

Prospective applicants are asked to submit a letter of
intent that includes the following information:

Descriptive title of proposed research;

Name, address, and telephone number of the
PD(s)/PI(s);

Names of other key personnel;

Participating institutions; and

Number and title of this funding opportunity
announcement.

Although a letter of intent is not required, is not
binding, and does not enter into the review of a subsequent application, the
information that it contains allows NCI staff members to estimate the potential
review workload and plan the review.

Applications
must be prepared using the research grant application forms found in the PHS
398 instructions for preparing a research grant application. Submit a signed,
typewritten original of the application, including the checklist, and three
signed photocopies in one package to:

Applications
must be received on or before the application receipt/ date(s) described above
(Section IV.3.A.). If an application
is received after that date, it will be returned to the applicant without
review.

Upon receipt,
applications will be evaluated for completeness by CSR. Incomplete
applications will not be reviewed.

The NIH will not
accept any application in response to this funding opportunity that is
essentially the same as one currently pending initial merit review unless the
applicant withdraws the pending application. The NIH will not accept any
application that is essentially the same as one already reviewed. However, the
NIH will accept a resubmission application, but such application must include
an Introduction addressing the critique from the previous review.

All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy
Statement.

Pre-award costs
are allowable. A grantee may, at its own risk and without NIH prior approval,
incur obligations and expenditures to cover costs up to 90 days before the
beginning date of the initial budget period of a new award if such costs: 1) are
necessary to conduct the project; and 2) would be allowable under the grant, if
awarded, without NIH prior approval. If specific expenditures would otherwise
require prior approval, the grantee must obtain NIH approval before incurring
the cost. NIH prior approval is required for any costs to be incurred more
than 90 days before the beginning date of the initial budget period of a new
award.

The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project
(see the NIH Grants Policy Statement at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

6. Other Submission
Requirements

Partnership
Structure. Each
P20 MI/CCP application must be submitted as a clearly documented partnership
between the MSI and the Cancer Center. For each partnership, two separate
applications must be submitted: one from the MSI and one from the Cancer Center. Each application may have multiple PIs but one PI from each partnering
institution is expected to be designated contact PI.

The P20 MI/CCP
application should follow the structure detailed below. The standard PHS 398 instructions (http://grants.nih.gov/grants/funding/phs398/phs398.html) and the standard
PHS398 Forms should be followed unless specific exceptions and/or additional
requirements are noted below.

A. Face
Page. The title of the partnership (Item 1) should be identical
for both the MSI and the Cancer Center linked applications. The title should be
unique to the specific partnership (do not repeat the title of this PA) and
should include the suffix (1 of 2) or (2 of 2) for applications from MSI
and Cancer Center, respectively. Attach additional Form Page 1 sheets for each
additional PI.

B. Summary, Relevance,
Project/Performance Sites, Senior/Key Personnel, Other Significant
Contributors, and Human Embryonic Stem Cells. List the contact PI first followed by the other PIs (the
contact PI on the partnership application should be included as one of the
PIs). Then list all Key Personnel for the Administrative Core and all Pilot
projects/program in this application in alphabetical order. Finally, list the
members of the IAC.

C. Detailed Budget for Initial
Budget Period.In addition to the standard Detailed Initial
Budget for the entire application, use separate PHS 398 Form Page 4 sheets to
provide individual detailed initial budget for each core. Separately, split the
budget into sections using different Form Page 4 sheets for each stage, as
follows: (i) Planning Stage; (ii) Priority-Setting Stage; and (iii)
Implementation Stage Budget. It is expected that total requested costs in the
first year will be less than costs in the subsequent second and/or third years,
since planning and priority-setting are not as expensive as the implementation
of a project or a program.

D. Budget for Entire Proposed Period of Support. In addition to the standard Budget for Entire Proposed
Period of Support for the entire application, use separate PHS 398 Form Page 5
sheets to provide individual budgets for each stage of partnership development
during the entire proposed period of support (i.e., separate budgets for the
entire period of support for: (i) planning stage; (ii) priority-setting stage;
and (iii) implementation stage). Use PHS398 Form Page 5 for the entire
application (and continuation sheets, if needed) to provide budget
justification. Provide specific justifications for costs for each year requested,
and what is appropriate to the stage of development. The costs for each year
would include administrative costs and developmental costs as needed within the
$275,000 direct cost cap (together for both linked applications).

E. Budgets Pertaining to Consortium/Contractual
Arrangements. Follow the PHS398
instructions to complete this information if the application (either the MSI
application or Cancer Center application) involves a consortium of more than
one institution of its type. One of these institutions will serve as the
primary applicant institution (the one formally submitting the application)
whereas the other will be involved under a subcontract.

F. Biographical Sketches. Follow the PHS398 instructions and use the PHS 398
Biographical Sketch Format Page to provide biosketches (not to exceed four
pages each) for all the individuals listed on Form Page 2 (collated in the same
order).

G. Research Plan.

In order to match the unique needs of
the MI/CCP application, the Research Strategy section should include
the Sections below.

The other sections of the PHS 398
Research Plan should be completed as per standard PHS 398 instructions.

Introduction to Revised/Resubmission (if applicable; not
to exceed 1 page): This section
should be identical for both the MSI and Cancer Center applications. Include a
summary of the additions, deletions, and changes in the revised application,
placing particular emphasis on responses to the criticisms and issues raised in
the previous summary statement. In addition, include a chronological
description of activities conducted since the original submission (meetings,
research activities, etc.). The important changes must be clearly marked in the
text.

Section 1 in Overall Research
Strategy. Background and Objectives: This section should be identical for both the MSI and
the Cancer Center linked applications (not to exceed 6 pages). Describe the characteristics of the MSI and the Cancer
Center that will contribute to the planning effort. The description should
clearly denote the nature of the interactions and deliberations that occurred
between the MSI and the Cancer Center during the preparation of these
applications (and identify the individuals involved). State the objectives of
the collaboration.

Section 2 in Overall Research
Strategy. Letters-of-Commitment: This section
should be different for the MSI and Cancer Center applications in the linked
pair. The section must contain Letters-of-Commitment from the MSI leadership
and the Cancer Center leadership that document: (i) full support of the
proposed activities; and (ii) any commitment of resources necessary to ensure
that these partnerships will have the maximum chance of success. A complete and
specific description of such resources would include the following:

A specific statement detailing the percent effort of
release/protected time of faculty (MSI
lead PI: a minimum of 10 percent of effort and 25% of effort if there are
no other PIs from the MSI side of the partnership: lead PI from the Cancer
Center: a minimum of 10 percent of effort regardless of the number of PIs
from the CC side of the partnership) as well as the activities that each faculty
involved are being released from (e.g., teaching, clinical, administrative
duties);

Provisions for space and facilities for new projects/programs,
capital improvements, recruitment of new faculty, and other resources that
will ensure the success of the partnership. This is especially important
in cases where the application will require significant institutional
commitments to ensure its success, such as a training program or an
education program. The commitments must come from both institutional
leaders of the MSI (e.g., President, Dean) and the Cancer Center (e.g.,
Cancer Center Director); and

If the Principal Investigators of the MSI or Cancer Center are less
experienced individuals, a letter of support should be from a senior
member of the MSI (e.g., Department Chair, Dean), or Cancer Center (e.g.,
Dean, Cancer Center Director). This letter of support should include a
statement describing how the Principal Investigator(s) will be provided
with appropriate mentoring and the necessary support to ensure the success
of this collaborative planning effort. This support could be in the form
of protected time for junior faculty to participate in and focus on the
objectives of this grant and discretionary resources that will be made
available to the Principal Investigators (See Section I. Scope).

Section 3 of Overall Research
Strategy. Chronological Estimate of Planning,
Priority-Setting, and Implementation Stages: This section
should be identical for both the MSI and the Cancer Center application.
Include a chronological narrative or table listing the specific first year,
second year, third year, and fourth year objectives that are expected to be
achieved. For each objective, a brief statement should be made about the
separate contributions of the MSI and the Cancer Center in order to achieve
success. The final objective of the P20 must be the submission of a specific
grant application (R03, R01, T32, K12, R25T, R25E, project on Program Project
Research Grant [P01], or Spore Grant [P50]) to the NCI or other funding
agencies.

Section 4 of Overall Research
Strategy. Initial Planning Stage: This section
should be identical for both the MSI and the Cancer Center application. The
applicants should clearly describe the kinds of planning activities that the MSI and
the Cancer Center will conduct to ensure a highly interactive and integrated
effort between their faculty and scientists. These applicants should also
relate each planning activity (e.g., workshop, retreat, executive meeting) to
specific objectives above and name the specific faculty and interests (e.g.,
training, clinical oncology researchers, research in prostate cancer,
establishing new curriculum in cancer health disparities, nutrition, etc.)
involved in each activity.

Section 5 of Overall Research
Strategy. Priority-Setting Stage: This section should be identical for both the MSI and
the Cancer Center applications. Clearly describe how the specific
projects/programs will be prioritized and selected for implementation based on
their merit and greatest potential for success.

In addition to the Overall
Research Strategy, an additional
section is allowed for the Research Plan for each
project covered in the Implementation
Stage as described below.

Research Strategy for Implementation
Stage of each Project: In this section, the application must describe at least one (required) or more
joint pilot Projects/Programs in any of the four targeted areas (cancer
research; cancer training and career development; cancer education; and cancer outreach). The Pilot Projects/Programs proposed for funding cannot
exceed $120,000 per project/program in direct costs per year for up to 3 years.

This
section should be identical for both the MSI and the Cancer Center
applications, and does not count toward the overall page limits for
the Overall Research Strategy. Each project should have a separate
Research Plan.

The description of each joint pilot projects/programs should be provided in the following format:

Title Page including: project/program title, names of
co-leaders from the MSI and the Cancer Center, and one paragraph abstract
stating the objectives of the project/program (not counted towards the
page limits);

Detailed budget page for initial budget period (using Form Page 4 of the Form PHS 398; not
counted toward the page limits);

Budget for the entire proposed period of support (using Form Page 5 from the Form PHS 398, not
counted towards the page limits);

Biographical Sketches of Co-Leaders (even if already included among the biosketches for the entire
application);

Research Plan (using standard
Sections as per PHS398 instructions).

Specific Aims (must not exceed one page)

Research Strategymust not exceed 6 pages per each project/program.

Describe how this pilot project/program relates to the overall
priorities of the partnership and the target area(s). Include any
preliminary data (if available). Describe, as appropriate for the nature
of the project/program, experimental methods/study design, or the
training, outreach and/or education plans and objectives. For example,
include the identification of the target pool (students or minority
population), and/or the method of program evaluation and tracking.
Describe the role played by the MSI and Cancer Center co-investigators/
mentors. Identify which aspects of the pilot project/program will be
conducted primarily at the MSI and which at the Cancer Center. Research
projects/programs conducted primarily at the MSI may be in any area of cancer
research, but research projects/programs conducted primarily at the Cancer Center
must specifically address cancer health disparities research.

Other Sections of PHS 398 Research Plan must also
be completed for each pilot project/program (but are excluded from page limitations).

Career Development and Mentorship Plan (if needed). For the less experienced co-leaders, A Career
Development and Mentorship Plan should be provided. The plan
description should follow the format of Career Development Awards (K
Awards), Section II. Specialized Information, sub-sections: 1. The
Candidate; 2. Statements by Sponsor, Co-Sponsor(s),*Consultant(s),* and
Contributor(s); and 3. Environment and Institutional Commitment to
Candidate (http://grants.nih.gov/grants/funding/phs398/phs398.html). If included,the Research Strategy page limit is expanded to 12 pages in total. In case of a PI
for whom a career development plan is already required and included under
new Overall Research Strategy Section 3, refer to that section.

**NOTE:
(1) All NIH-supported biomedical or behavioral research projects involving
human subjects must consider appropriate inclusion of Gender and Minorities and
Children as noted in the PHS 398 application instructions; (2) Research dealing with Human Subjects and Vertebrate Animals must be accompanied
by appropriate documentation as described in the PHS 398 application
instructions; and (3) Research components involving clinical trials must
include provisions for rigorous data management, quality assurance, and
auditing procedures. Funds should be budgeted for these activities and should
be justified. The proposed provisions should not duplicate review and
monitoring systems already in place at the institution.

For
any cancer treatment protocol supported directly or indirectly by the P20
MI/CCP, informed consent forms, early stopping rules, and procedures to detect
and monitor adverse drug reactions (ADR) must be provided in the application,
or in the case of protocols subsequent to funding of a P20 MI/CCP, to the NCI
program director.

Do not use the Appendix to circumvent the page limitations.
An application that does not observe the required page limitations may be
delayed in the review process.

Resource Sharing
Plan(s)

NIH
considers the sharing of unique research resources developed through
NIH-sponsored research an important means to enhance the value of, and advance,
research. When resources have been developed with NIH funds and the associated
research findings published or provided to NIH, it is important that they be
made readily available for research purposes to qualified individuals within
the scientific community. If the final data/resources
are not amenable to sharing, this must be explained in Resource Sharing section
of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).

(b) Sharing Model Organisms:
Regardless of the amount requested, all applications where the development of
model organisms is anticipated are expectedto include a
description of a specific plan for sharing and distributing unique model
organisms and related resources, or state appropriate reasons why such sharing
is restricted or not possible. See Sharing Model Organisms Policy and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a
genome-wide association study are expected to provide a plan for
submission of GWAS data to the NIH-designatedGWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. A genome-wide association study is defined as
any study of genetic variation across the entire genome that is designed to
identify genetic associations with observable traits (such as blood pressure or
weight) or the presence or absence of a disease or condition. For further
information see Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide
NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Section
V. Application Review Information

1. Criteria

Only the review criteria
described below will be considered in the review process.

2. Review and Selection Process

Applications that are complete will be
evaluated for scientific and technical merit by (an) appropriate scientific review group convened by the
National Cancer Institute and in accordance
with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.

As
part of the scientific peer review, all applications will:

Undergo
a selection process in which only those applications deemed to have the
highest scientific and technical merit, generally the top half of
applications under review, will be discussed and assigned an
impact/priority score;

Receive
a written critique; and

Receive a second level
of review by
the National Cancer Advisory Board.

Applications
submitted in response to this funding opportunity will compete for available
funds with all other recommended applications. The following will be
considered in making funding decisions:

Scientific
merit of the proposed project as determined by scientific peer review;

Availability
of funds; and

Relevance
of the proposed project to program priorities.

The mission
of the NIH is to support science in pursuit of knowledge about the biology and
behavior of living systems and to apply that knowledge to extend healthy life
and reduce the burdens of illness and disability. As part of this
mission, applications submitted to the NIH for grants or cooperative agreements
to support biomedical and behavioral research are evaluated for scientific and
technical merit through the NIH peer review system.

Overall
Impact. Reviewers will provide an overall impact/priority
score to reflect their assessment of the likelihood for the project to exert a
sustained, powerful influence on the research field(s) involved, in
consideration of the following five core review criteria, and additional review
criteria (as applicable for the project proposed).

Core Review
Criteria. Reviewers will consider each of the five
review criteria below in the determination of scientific and technical merit,
and give a separate score for each. An application does not need to be
strong in all categories to be judged likely to have major scientific
impact. For example, a project that by its nature is not innovative may
be essential to advance a field.

Significance. Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change
the concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Investigator(s). Are the PD/PIs, collaborators, and other
researchers well suited to the project? If Early Stage Investigators or
New Investigators, do they have appropriate experience and training? If
established, have they demonstrated an ongoing record of accomplishments that
have advanced their field(s)? If the project is collaborative or
multi-PD/PI, do the investigators have complementary and integrated expertise;
are their leadership approach, governance and organizational structure
appropriate for the project? Are the strengths, academic qualifications
and biomedical expertise of the project investigators appropriate and
sufficient for research productivity?

Innovation. Does the application challenge and seek
to shift current research or clinical practice paradigms by utilizing novel
theoretical concepts, approaches or methodologies, instrumentation, or
interventions? Are the concepts, approaches or methodologies, instrumentation,
or interventions novel to one field of research or novel in a broad
sense? Is a refinement, improvement, or new application of theoretical
concepts, approaches or methodologies, instrumentation, or interventions
proposed?

Approach. Are the overall strategy, methodology, and
analyses well-reasoned and appropriate to accomplish the specific aims of the
project? Are potential problems, alternative strategies, and benchmarks
for success presented? If the project is in the early stages of development,
will the strategy establish feasibility and will particularly risky aspects be
managed?

If the project involves clinical research,
are the plans for 1) Protections for Human Subjects, and 2)
inclusion of minorities and members of both sexes/genders, as well as the
inclusion of children, justified in terms of the scientific goals and research
strategy proposed?

In addition, specific to this FOA, the additional review
criteria will be considered for Approach:

1. Approach. MSI-Cancer Center Partnership-specific
aspects:

a) Initial Planning Stage

Are the different planning methods proposed by the MSI and the
Cancer Center to explore areas of research and training opportunities
adequate to ensure highly interactive and integrated efforts between
individual scientists (e.g., research cancer project) and/or between
faculty and scientists (e.g., training program, education program)?

Is the duration of the initial planning stage needed to identify
areas of potential collaboration, adequate?

b) Priority-Setting Stage

Are the qualifications and experience of the individuals from the
IAC who will take part in prioritizing and selecting specific pilot
projects/programs for implementation appropriate or adequate?

Is the proposed process for selecting pilot projects/programs for
implementation based on their merit and their potential for successful
acquisition of preliminary data during the period of requested grant
support, adequate?

c) Pilot Research Project(s) (if applicable)

What are the qualifications of the co-Investigators collaborating
in the pilot project to implement the research pilot project and what
is the relevance of the research to the goals and priorities of the
partnership?

What is the merit of the project/program and its potential to
acquire the necessary preliminary data to become competitive for specific
grant support (e.g., as provided through the R03, R01, P01, R21,
T32, R25, K12, etc., grant award mechanisms)?

Is the Career Development and Mentorship Plan (if needed) adequate?

d) Pilot Program(s) (i.e., training and education, if
applicable)

What are the qualifications of the Co-Leaders from the MSI and the
Cancer Center to develop the proposed program?

Is/are thementor(s) appropriate as related to the level of
education of the trainees?

What are the objectives, design, and direction of the program?

What is the merit of the proposed program and its relation to the
goals and priorities of the partnership?

Is the quality of the institutional environment (access to institutional
resources, mentors accessibility, etc.) adequate?

Is there evidence of integrating the proposed program with other
program(s) in the MSI and the Cancer Center?

What is the quality of the proposed program evaluation and the
tracking process?

What is the potential of the pilot program application to develop
into a competitive program for funding from the NIH or other agency?

Environment. Will the scientific environment in which the
work will be done contribute to the probability of success? Are the
institutional support, equipment and other physical resources available to the
investigators adequate for the project proposed? Will the project benefit
from unique features of the scientific environment, subject populations, or
collaborative arrangements?

In addition, specific to this FOA, the additional review
criteria will be considered for Environment(MSI-Cancer Center
Partnership-specific):

Collaboration in Partnership

What is the strength of the evidence that the researchers and
faculty of the MSI and the Cancer Center worked closely together in the
preparation of the application?

To what degree do the letters-of-support from senior faculty and/or
institutional/center leaders address the need for mentoring of
inexperienced PIs or for specific institutional/center commitments to
ensure the success of the collaboration?

If any of the MSI PIs are junior investigators, is an adequate
Career Development and Mentorship Plan described?

As applicable, are the provisions made for day-to-day oversight,
coordination, support, and logistical services needed to make the
collaboration successful, adequate?

Does the application
employ useful collaborative arrangements? Is there evidence of
institutional support?

The linked applications submitted in response to this FOA
will be reviewed together and will receive one (i.e., the same) impact/priority
score.

Additional Review Criteria

As applicable for the project
proposed, reviewers will consider the following additional items in the
determination of scientific and technical merit, but will not give separate
scores for these items.

Protections for Human Subjects. For
research that involves human subjects but does not involve one of the six
categories of research that are exempt under 45 CFR Part 46, the committee will
evaluate the justification for involvement of human subjects and the proposed
protections from research risk relating to their participation according to the
following five review criteria: 1) risk to subjects, 2) adequacy of protection
against risks, 3) potential benefits to the subjects and others, 4) importance
of the knowledge to be gained, and 5) data and safety monitoring for clinical
trials.

For research that involves human subjects and meets
the criteria for one or more of the six categories of research that are exempt
under 45 CFR Part 46, the committee will evaluate: 1) the justification for the
exemption, 2) human subjects involvement and characteristics, and 3) sources of
materials.

Inclusion of Women, Minorities, and Children.
When the proposed project involves clinical research, the committee will
evaluate the proposed plans for inclusion of minorities and members of both
genders, as well as the inclusion of children.

Vertebrate Animals. The committee
will evaluate the involvement of live vertebrate animals as part of the
scientific assessment according to the following five points: 1) proposed use of
the animals, and species, strains, ages, sex, and numbers to be used; 2)
justifications for the use of animals and for the appropriateness of the species
and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting
discomfort, distress, pain and injury to that which is unavoidable in the
conduct of scientifically sound research including the use of analgesic,
anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and
5) methods of euthanasia and reason for selection if not consistent with the
AVMA Guidelines on Euthanasia.

Resubmission Applications. When
reviewing a Resubmission application (formerly called an amended application),
the committee will evaluate the application as now presented, taking into
consideration the responses to comments from the previous scientific review
group and changes made to the project.

Renewal Applications. When reviewing
a Renewal application (formerly called a competing continuation application),
the committee will consider the progress made in the last funding period.

Revision Applications. When
reviewing a Revision application (formerly called a competing supplement
application), the committee will consider the appropriateness of the proposed
expansion of the scope of the project. If the Revision application relates to a
specific line of investigation presented in the original application that was
not recommended for approval by the committee, then the committee will consider
whether the responses to comments from the previous scientific review group are
adequate and whether substantial changes are clearly evident.

Biohazards. Reviewers will assess
whether materials or procedures proposed are potentially hazardous to research
personnel and/or the environment, and if needed, determine whether adequate
protection is proposed.

Additional Review Considerations

As applicable for the
project proposed, reviewers will address each of the following items, but will
not give scores for these items and should not consider them in providing an
overall impact score.

Budget and Period Support. Reviewers
will consider whether the budget and the requested period of support are fully
justified and reasonable in relation to the proposed research.

Select Agents Research. Reviewers
will assess the information provided in this section of the application,
including 1) the Select Agent(s) to be used in the proposed research, 2) the
registration status of all entities where Select Agent(s) will be used, 3) the
procedures that will be used to monitor possession use and transfer of Select
Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security
of the Select Agent(s).

Applications from Foreign Organizations.
Reviewers will assess whether the project presents special opportunities for
furthering research programs through the use of unusual talent, resources,
populations, or environmental conditions that exist in other countries and
either are not readily available in the United States or augment existing U.S.
resources.

Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NOA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See also Section IV.5. Funding
Restrictions.

A
formal notification in the form of a Notice ofAward (NoA) will be
provided to the applicant organization. The NoA signed by the grants
management officer is the authorizing document. Once all administrative and
programmatic issues have been resolved, the NoA will be generated via email
notification from the awarding component to the grantee business official
(designated in item 12 on the Application Face Page). If a grantee is not
email enabled, a hard copy of the NoA will be mailed to the business official.

A
final progress report, invention statement, and Financial Status Report are
required when an award is relinquished when a recipient changes institutions or
when an award is terminated.

Section
VII. Agency Contacts

We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research; peer review; and financial or grants
management issues.

Human Subjects Protection:Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(phase I); efficacy studies (Phase II); efficacy, effectiveness, and
comparative trials (Phase III). Monitoring should be commensurate with risk.
The establishment of data and safety monitoring boards (DSMBs) is required for
multi-site clinical trials involving interventions that entail potential risks
to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their
institutions, on issues related to institutional policies and
local IRB rules, as well as local, State and Federal laws and regulations, including
the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the impact/priority score.

Policy for Genome-Wide
Association Studies (GWAS):NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic variation
across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH
Guide NOT-OD-07-088. For additional information,
see http://grants.nih.gov/grants/gwas/

Sharing of Model Organisms:NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model
organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH
recognizes the rights of grantees and contractors to elect and retain title to
subject inventions developed with Federal funding pursuant to the Bayh Dole Act
(see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators
submitting an NIH application or contract proposal, beginning with the October
1, 2004 receipt date, are expected to include in the application/proposal a
description of a specific plan for sharing and distributing unique model
organism research resources generated using NIH funding or state why such
sharing is restricted or not possible. This will permit other researchers to
benefit from the resources developed with public funding. The inclusion of a
model organism sharing plan is not subject to a cost threshold in any year and
is expected to be included in all applications where the development of model
organisms is anticipated.

Access to Research Data through the Freedom of
Information Act:The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are (1) first
produced in a project that is supported in whole or in part with Federal funds
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic
scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to
place data collected under this funding opportunity in a public archive, which
can provide protections for the data and manage the distribution for an
indefinite period of time. If so, the application should include a description
of the archiving plan in the study design and include information about this in
the budget justification section of the application. In addition, applicants
should think about how to structure informed consent statements and other human
subjects procedures given the potential for wider use of data collected under
this award.

Inclusion of Women, Minorities, and Children:It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the
updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy
incorporates: the use of an NIH definition of clinical research; updated racial
and ethnic categories in compliance with the new OMB standards; clarification
of language governing NIH-defined Phase III clinical trials consistent with the
new PHS Form 398; and updated roles and responsibilities of NIH staff and the
extramural community. The policy continues to require for all NIH-defined Phase
III clinical trials that: a) all applications or proposals and/or protocols
must provide a description of plans to conduct analyses, as appropriate, to
address differences by sex/gender and/or racial/ethnic groups, including
subgroups if applicable; and b) investigators must report annual accrual and
progress in conducting analyses, as appropriate, by sex/gender and/or
racial/ethnic group differences.

Inclusion of Children as Participants in Clinical
Research:The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them. All investigators proposing research involving
human subjects should read the "NIH Policy and Guidelines" on the
inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject
Participants:NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

NIH
Public Access Policy Requirement:In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html),
investigators must submit or have submitted for them their final, peer-reviewed
manuscripts that arise from NIH funds and are accepted for publication as of
April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be
made publicly available no later than 12 months after publication. As of May
27, 2008, investigators must include the PubMed Central reference number when
citing an article in NIH applications, proposals, and progress reports that
fall under the policy, and was authored or co-authored by the investigator or
arose from the investigators NIH award. For more information, see the Public
Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable
Health Information:The Department of
Health and Human Services (DHHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the DHHS
Office for Civil Rights (OCR).

Decisions about
applicability and implementation of the Privacy Rule reside with the researcher
and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the
Privacy Rule, including a complete Regulation Text and a set of decision tools
on "Am I a covered entity?" Information on the impact of the HIPAA
Privacy Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts can be
found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant
Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within
specified page limitations. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution
reviewers that their anonymity may be compromised when they directly access an
Internet site.

Healthy People 2010:The Public
Health Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.

Authority
and Regulations:This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive
Order 12372. Awards are made under the authorization of Sections 301 and 405 of
the Public Health Service Act as amended (42 USC 241 and 284) and under Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the
terms and conditions, cost principles, and other considerations described in
the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.

Loan
Repayment Programs:NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov/.